drugset / Trial / NCT02495844
A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is to assess the efficacy, safety, and tolerability of the investigational drug UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in Europe.
Timeline
- Start
- 2015-07
- Primary completion
- 2017-02
- Completion
- 2017-07
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo/UCB0942 (FAS) vs UCB0942/UCB0942 (FAS); p =0.0679; Odds Ratio (OR) 4.14 (95% CI 0.90 to 19.06); Regression, Logistic NCT02495844 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Padsevonil | Small molecule | 100 mg | Oral |
| Subject | Padsevonil | Small molecule | 200 mg | Oral |